Health TrialsbyHealthPanel

Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia

ConditionsSLE (Systemic Lupus)CMV
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital

About this trial

This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the American College of Rheumatology criteria for the diagnosis of SLE.

The test for plasma CMV DNA viral load is positive.

Age: 18 to 65 years, weight 45-80kg, male or female, gender ratio is not limited.

Apply corticosteroid less than 1.0mg/kg/d.

Disqualifiers

Inability to comply with IL-2 treatment regimen;

Other active infections. (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus, Mycobacterium tuberculosis or pneumocystis carinii pneumonia)

Any anti-CMV vaccine within 6 months;

History of intravenous immunoglobulin (IVIG) or leflunomide within 6 months prior to randomization, and those who have undergone plasmapheresis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interleukin-2 (IL-2)

    Drug

    Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity.

  • Ganciclovir (GCV)

    Drug

    Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: IL-2 groupExperimental treatment 2 interventions
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Changes of NK cell levels

Changes of absolute NK cell count and NK%.

Time frame
Baseline and week 12

Secondary outcomes

1

Duration of CMV viremia

Duration of CMV viremia is defined as the time interval between detection of positive CMV DNA load in plasma and CMV negativity.

Time frame
From enrollment to the end of treatment
2

Change of CMV titers

The change (decline) of CMV titers from baseline

Time frame
From enrollment to the end of treatment
3

Immune responses

Changes of levels of immunoglobulins and lymphocyte subtypes, including T/B lymphocytes, Treg, Th1/2/17.

Time frame
Baseline and Week 12
4

• Complements levels

Changes of levels of complement 3/4 (C3/C4)

Time frame
Baseline and week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: